MAUDE Adverse Event Report: Medline Industries, LP CURAD; BANDAGE,PLASTIC,CURAD,3/4"X3",1

Catalog Number	CUR02278RBZ
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "bandaids are not sticking".
Additional Manufacturer Narrative
The customer called in and said the bandage "it doesnt stick"; the customer reported no allergic reaction or skin irritation, and the bandage was applied to the arm.Despite multiple attempts, neither a sample nor photos of the reported issue were provided, and analysis of complaint data was performed with trending conducted over the past two years by all versions of the product.Based on the information provided, medline was not able to confirm the reported issue or that the product failed to meet specifications; the cause was listed as "sample required to determine cause" and "unconfirmed defect." in the event additional information becomes available, this complaint will be reopened, updated, and investigated as necessary, and complaints are monitored via the trend analysis procedure.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CURAD
• Common Device Name: BANDAGE,PLASTIC,CURAD,3/4"X3",1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50732357
• Report Number: 1417592-2026-36804
• Device Sequence Number: 10591895
• Product Code: KGX
• UDI-Device Identifier: 00080196302829
• UDI-Public: 00080196302829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CUR02278RBZ
• Device Lot Number: 18044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown